GFS - Sterile Screws and Top Hat
FDA 510(k) K253858 · T.A.G. Medical Products Corporation, Ltd.
510(k) numberK253858
Submission
- Device name
- GFS - Sterile Screws and Top Hat
- Applicant
- T.A.G. Medical Products Corporation, Ltd.
Gaaton Northern, IL - Received
- December 3, 2025
- Decision date
- August 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation NailHWC · Traditional | OSSIO , Ltd. | 05/01/2026SE |
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| K230058 | Bladeless Trocar Artemis Lap CannulaGCJ · Traditional | 04/28/2023SE |
| K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…MBI · Traditional | 09/07/2022SE |
| K210498 | Betta Link Knotless Implant SystemMBI · Special | 03/24/2021SE |
| K202178 | VersaLoop Anchor SystemMBI · Traditional | 11/13/2020SE |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…MBI · Traditional | 05/19/2019SE |
| K143326 | T.A.G. Dental Implant SystemDZE · Traditional | 05/14/2015SE |
| K142653 | G-Lok and G-Lok XL ExtenderMBI · Special | 10/16/2014SE |
| K113297 | Knotilus Anchor SystemMBI · Traditional | 03/02/2012SE |
| K112296 | Lateral ButtonMBI · Traditional | 12/01/2011SE |
Questions and answers
When was GFS - Sterile Screws and Top Hat cleared by the FDA?
GFS - Sterile Screws and Top Hat (K253858) received a 510(k) decision of Substantially Equivalent on August 5, 2026, 245 days after the submission was received.
What is the product code of K253858?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.